Drugs

CGMP Violations at Taka USA

A 6/3-6/6/19 FDA inspection at Taka USA, doing business as Cosmetic Innovations, Carrollton, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/29 Warning Letter says specific violations were:

failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failing to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess;
failing to conduct at least one test to verify the identity of each component of a drug product, and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals; and
failing to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

FDA says that based on the nature of the violations identified at the firm, it recommends that Taka engage a qualified consultant to assist it in meeting CGMP requirements. The agency also recommends that a qualified third-party consultant perform a comprehensive audit of Taka’s operations and evaluate the effectiveness of its corrective and preventive actions.

Taka was told to respond with specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the actions.

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